Molecular Medicine Israel

FDA Reform to Boost US Economy?

Two experts propose replacing Phase 3 trials with smaller, faster alternatives and post-market surveillance to invigorate the pharmaceutical industry

By phasing out Phase 3 trials and thus lowering the barriers facing drug development in the United States, the Food and Drug Administration (FDA) could improve the health of millions and spur economic growth, argued Tomas Philips, a public policy expert at the University of Chicago, and Andrew von Eschenbach, president of the Samaritan Health Initiatives and former FDA commissioner, this week (March 3) at Bloomberg View.

Noting the “glacial” pace of the drug approval process, Philips and von Eschenbach suggest that current output of new drugs could be doubled if the FDA altered its expensive and laborious clinical-trial requirements. Specifically, they contend that Phase 3 trials—in which the effectiveness of a candidate drug is assessed in large groups over extended periods of time—is doing more harm than good because it is severely reducing the pharmaceutical industry’s incentive to invest in new treatments….

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